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GCP QA Auditor - Clinical Trial Auditing

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POST DATE 9/7/2016
END DATE 10/18/2016

Chiltern Wilmington, NC

Company
Chiltern
Job Classification
Full Time
Company Ref #
3820/4354
AJE Ref #
576110520
Location
Wilmington, NC
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
High School Diploma or GED

JOB DESCRIPTION

APPLY
GCP QA AUDITOR - CLINICAL TRIAL AUDITING

JOB REFERENCE

3820/4354

JOB BACKGROUND

The QA Auditor is responsible for Quality Assurance aspects of clinical trials, ensuring trials conform to ICH-GCP, other applicable regulations and the relevant Standard Operating Procedures (SOPs). The QA Auditor is independent of the Clinical Research Team.

This position may be field based, based upon experience.

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

DUTIES & RESPONSIBILITIES

Accountabilities / Responsibilities:

1. Assist with planning, preparation, and implementation of trial specific, quality system, and vendor qualification audits and report findings to the auditees.
2. Assist with creation of SOPs required for the proper functioning of the clinical trial process. When instructed by QA Management, assist with evaluating and updating QA SOPs.
3. With guidance from line management and experienced colleagues, audit the quality of the clinical trial against the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements; prepare audit reports within a timely manner; identify any failure to meet the standards and escalate the issue with the Project Manager; and if required, with Chiltern Senior Management.
4. With guidance from line management and experienced colleagues, conduct project specific, internal system audits and vendor audits to assess the quality standards and provide recommendations; prepare audit reports within a timely manner.
5. Actively participate in training sessions and workshops, including presenting
reports from any conferences attended.
6. Ensure timely completion and documentation of all training requirements.
7. Be aware of updates to regulations, guidelines and principles related to Good
Clinical Practice (GCP) and advise on their use and compliance.
8. Ensure that systems and processes agreed and implemented by management
will ensure that Clinical Trials have been performed, and data is generated, in
compliance with ICH-GCP and other applicable regulations.
9. Support the planning, preparation, and implementation of trial specific, quality
system, and vendor qualification audits and report findings to the auditees.
10. Support the creation of SOPs required for the proper functioning of the clinical
trial process. When instructed by QA Management, evaluate and update QA
SOPs.
11. Audit the quality of the clinical trials against the defined project-specific quality
and performance standards as well as relevant SOPs, ICH/GCP, and local
requirements; prepare audit reports within a timely manner; identify any
failure to meet the standards and escalate the issue immediately with the
Project Manager; and if required, with Chiltern Senior Management.
12. Conduct project specific, internal system audits and vendor audits to assess the
quality standards and provide recommendations; prepare audit reports within
a timely manner.
13. Other duties, as required by the Quality Assurance department.

REQUIREMENTS

Minimum Qualifications, Experience, Skills and Attributes:

Bilingual in Spanish and English is a plus

Education:
High School Diploma (or equivalent) required
University Degree in a biomedical or related life science, nursing or engineering qualification beneficial

Experience:
Minimum 2-4 years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.

Skills and Attributes:

* Diplomatic and professional oral and written communication skills to be able to convey and discuss audit findings, good organisational skills and personal presentation.

* Methodical and meticulous, with excellent attention to detail.

* Ability to proactively manage multiple responsibilities and tasks.

* Experience working in a team environment under time and resource pressures.

* Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications

* Ability to review data and procedures in detail and the ability to see the greater overall perspective

* Understanding of the principles of ICH-GCP and all applicable regulatory requirements.

* Ability to guide, supervise and motivate less experienced staff.

* Ability to train junior members of the QA Compliance team on relevant QA systems, processes and procedures.

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

SALARY

Dependent on Experience

POSITION TYPE

Permanent
Full Time

CONTACT

Email Cheri Shedeck